We are currently evaluating survey platforms and are particularly interested in whether Qualtrics - either in its standard or any paid version—is FDA CFR Part 11 compliant.
This compliance is critical for some of our customers, especially in regulated environments such as clinical trials or healthcare research. However, we have not been able to find a definitive answer regarding Qualtrics' support for CFR Part 11 compliance.
When evaluating Part 11 compliance, we are specifically looking for the following features:
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Audit trails: To track all actions and modifications made to survey responses and settings.
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Electronic signatures: To ensure the authenticity and integrity of the data collected.
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Data integrity: To maintain accuracy and prevent tampering of collected information.
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Access control: To ensure only authorized users can view or modify data.
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Data security: To safeguard sensitive information from unauthorized access or breaches.
We understand that Qualtrics does offer strong capabilities in terms of data security, access control, and overall integrity. However, we are uncertain about:
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Whether audit trail functionality is available at a granular level.
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Whether the electronic signature feature meets the criteria for a Qualified Electronic Signature (QES), as required by CFR Part 11.
Based on our understanding, the e-signature functionality in Qualtrics may currently fall under a Simple Electronic Signature (SES). If that is the case, we are considering a potential workaround by redirecting participants to a third-party service like DocuSign (which supports QES) to capture compliant signatures, and then returning them to the Qualtrics survey flow.
Any official clarification or documentation regarding Qualtrics' support for 21 CFR Part 11, or potential configurations that would help us achieve compliance, would be greatly appreciated.